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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome.
This proposal explores the implications of our two recent major discoveries: the striking efficacy of the Selective Serotonin Reuptake Inhibitor (SSRI) sertraline in the control of the Night Eating Syndrome (NES) and the unprecedented elevation in the level of serotonin transporter (SERT) binding in the midbrain of persons with NES. Our overall theory is that NES is associated with a syndrome-specific increase in SERT derived from a genetic vulnerability which is affected by life stress. This increased SERT activity produces a fall in post-synaptic serotonin levels. The investigators hypothesize that these decreased serotonin levels result in a significant phase delay in circadian food intake manifested by evening hyperphagia, nighttime ingestions and morning anorexia. SSRIs that block this increased SERT activity increase synaptic serotonin levels and restore the circadian rhythm of food intake.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Night Eaters | Experimental | Subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test will also be administered no more than 48 hours before SPECT-CT imaging and the beginning of escitalopram oxalate (Lexapro) treatment. Escitalopram oxalate (Lexapro) open-label treatment will last 12 weeks. Dosing will start at 10 mg and increase to 20 mg per day flexibly. Treatment will be discontinued starting at 12 weeks under the supervision of our study physician. |
|
| Control Subjects | No Intervention | At the beginning of the study, control subjects will be given a medical history, height and weight will be measured, and BMI calculated. Initial outpatient assessment will include diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. An ADAM SPECT or SPECT-CT study of SERT binding will be conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects. The first procedure will be to assess SPECT or SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram oxalate | Drug | The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will be to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. Medication will be administered starting at 10 mg daily, with increase up to 20 mg, as indicated and tolerated, for up to three months. Visits will occur at baseline and weeks 1, 2, 4, 6, 8, 10, and 12. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Symptoms of NES | Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Nocturnal Ingestions | Number of nocturnal ingestions (waking and having something to eat) were reported at each visit. | 12 weeks |
| Night Eating Symptoms | The responses on the Night Eating Symptom Scale (NESS) will be examined over time. Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly C Allison, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Weight and Eating Disorders | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23557820 | Derived | Allison KC, Studt SK, Berkowitz RI, Hesson LA, Moore RH, Dubroff JG, Newberg A, Stunkard AJ. An open-label efficacy trial of escitalopram for night eating syndrome. Eat Behav. 2013 Apr;14(2):199-203. doi: 10.1016/j.eatbeh.2013.02.001. Epub 2013 Mar 5. |
| Label | URL |
|---|---|
| The Center for Weight and Eating Disorders | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Night Eaters | Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks. escitalopram oxalate: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12. |
| FG001 | Control Subjects | At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recruitment and Screening |
| |||||||||||||
| Imaging and Treatment (for NE Arm) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Night Eaters | 31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment. |
| BG001 | Control Subjects | 10 control participants completed the baseline screening and SPECT scans. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Symptoms of NES | Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit. | Posted | Mean | Standard Error | percentage of calories after dinner | 12 weeks |
|
Duration of the study - 12 weeks, open label with escitalopram oxalate
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Night Eating Syndrome Open Label Treatment Group | Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kelly C. Allison, Ph.D. | Perelman School of Medicine at the University of Pennsylvania | 215-898-2823 | kca@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D000074043 | Night Eating Syndrome |
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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|
|
| 12 weeks |
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Controls | The control participants did not participate in the treatment part of the study - only the baseline SPECT scans. |
|
|
| Secondary | Nocturnal Ingestions | Number of nocturnal ingestions (waking and having something to eat) were reported at each visit. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| Secondary | Night Eating Symptoms | The responses on the Night Eating Symptom Scale (NESS) will be examined over time. Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms. | Posted | Mean | Standard Error | units on a scale | 12 weeks |
|
|
|
| 0 |
| 31 |
| 5 |
| 31 |
| drowsiness | Nervous system disorders | Non-systematic Assessment |
|
| dry mouth | General disorders | Non-systematic Assessment |
|
| increased sweating | General disorders | Non-systematic Assessment |
|
| impotence/low libido | Reproductive system and breast disorders | Non-systematic Assessment |
|
| headache | Nervous system disorders | Non-systematic Assessment |
|
| mental cloudiness | Nervous system disorders | Non-systematic Assessment |
|
| diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |